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FDA 510(k)

DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR

K-Number: K021747 · 2002-08-15

ApplicantSurgicon, Inc.
Decision Date2002-08-15
Product CodeGCI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgicon, Inc.. It received FDA 510(k) clearance on 2002-08-15 under 510(k) number K021747. The device is classified under product code GCI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR?

DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR is a medical device that received FDA 510(k) clearance on 2002-08-15. The listed applicant is Surgicon, Inc.. The 510(k) number is K021747.

When did DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR receive FDA 510(k) clearance?

DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR received FDA 510(k) clearance on 2002-08-15, under 510(k) number K021747.

Who is the listed applicant for DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR?

The FDA 510(k) record lists Surgicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR?

The FDA product code for DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR is GCI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Surgicon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033359DEGALL II GALLBLADDER EXTRACTOR

Related Devices (Code: GCI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003222MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTERComputer Motion, Inc.K001362KARL STORZ 3D VIDEO SYSTEMKarl Storz Imaging, Inc.K933515BOOTY ENDOSCOPE WARMERT-Med, Inc.K930302BIRTCHER SURE CLEAN INSTRUMENT SYSTEMBirtcher Medical Systems, Inc.K930496GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPSBirtcher Medical Systems, Inc.K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHUnited States Surgical, A Division of Tyco Healthc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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